InfectionNCT00363220
Community - Associated Extended-spectrum Beta-lactamases (ESBL)
An observational study of Infection and E Coli Infections, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to review patients with E. coli infections at the University of Pittsburgh Medical Center (UPMC) from September 1, 2006 to August 31, 2007 to determine if these infections have arisen in the community rather than in hospitals or nursing homes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infection, E Coli Infections, Klebsiella Infections
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ESBL infections
Who may be able to join
- All patients with E. coli, Klebsiella species, and Proteus species infections during the time period of the study will be reviewed. A community-associated E. coli isolate will be defined as one which was recovered from a clinical culture from a patient at UPMC who had no established risk factors for infection with an antibiotic resistant organism. Established risk factors are defined as:
- Isolation of the organism two or more days after admission for hospitalization OR
- History of hospitalization, surgery, dialysis, or residence in a long-term care facility within one year before the culture date OR
- The presence of an indwelling catheter or percutaneous medical device (eg, tracheostomy tube, gastrostomy tube, or Foley catheter) at the time of the culture OR
- Previous isolation of an antibiotic resistant organism.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
The purpose of this study is to review patients with E. coli infections at the University of Pittsburgh Medical Center (UPMC) from September 1, 2006 to August 31, 2007 to determine if these infections have arisen in the community rather than in hospitals or nursing homes. The occurrence of such resistant isolates could be devastating if they were associated with bloodstream infection, such as sometimes accompanies a urinary tract infection, since antibiotic resistant E. coli is not suspected in isolates coming from the community. Therefore, the aims of this study are to:
- Review whether extended-spectrum beta-lactamase (ESBL)-producing organisms (E. coli, Klebsiella species and Proteus species) are hospital-acquired, healthcare-associated, or community-associated.
- Investigate the prevalence of ESBL-positive E. coli in foodstuffs (beef, poultry, turkey, and pork), as a potential source for ESBL producers in the community.
- Compare the clonal relationship of the genome and resistance plasmids carried by the ESBL-producing isolates (healthcare-associated, community-associated, and of animal origin) and study the associations of ESBL-mediated resistance with resistance to other classes of antimicrobials.
Read the detailed description
The following variables will be followed: age, sex, occupation, hospital location at the time of positive culture (ER, medical ward, ICU, etc.), prior hospitalization or nursing home admission, receipt of outpatient dialysis, home care or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, and prior positive microbiologic cultures. All sites are collecting the following information that was collected as part of the patient's clinical treatment. The following variables will be collected at all sites: time and location of positive cultures, underlying diseases and severity of illness, presence of urinary or intravascular devices, recent immunomodulative therapies or radiation therapy, physical exam findings, laboratory and radiographical data, antimicrobial usage within 30 days of onset of the infection, microbiological data and resistance patterns, choice of antibiotics once the organism is identified, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome, gender, height, weight, ethnicity, and past medical history. We will collect information prospectively for one year. The bacteria in the patient's cultures will be subcultured (after the diagnosis has been obtained since the microbiology lab would otherwise destroy the culture) and provided to the honest broker who will de-identify the specimen and link it to the medical information collected (which will also be de-identified by the honest broker). The following evaluation will be performed on these samples. The minimal inhibitory concentration of the antibiotic used in treatment will be performed by the E-Test method (AB Biodisk, Solna, Sweden). Specific mechanisms of antimicrobial resistance will be studied with emphasis on the presence of beta-lactamases produced by the bacteria. This evaluation will be performed by analytical isoelectric focusing techniques as well as PCR and gene sequencing analysis to determine genes encoding beta-lactamases. Biologic samples will be under the control of the principal investigator of this research project. All samples provided to the investigators are de-identified by the honest broker and will be coded with numbers. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location that only the honest broker has access to. The investigators on this study will keep the samples indefinitely. Samples will be kept in the investigator's laboratory located in Scaife Hall, room 812, 3500 Terrace Street. At no time will the research investigators have access to any patient identifiers. Medical record information and bacteria samples from facilities outside of UPMC will be provided to the PI de-identified. At no time will anyone on the research team have access to patient identifiers. All information and bacteria are collected as part of the patient's clinical treatment.
- Keywords
- Infection, E coli, Klebsiella, ESBL
- Medical subject headings
- Infections, Escherichia coli Infections, Klebsiella Infections, Proteus Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yohei Doi, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363220
- Sponsor's protocol ID
- IRB# 0607059
- Other IDs
- physician own funding
- Status last verified
- Dec 2015
- First submitted
- 10 Aug 2006
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community - Associated Extended-spectrum Beta-lactamases (ESBL)
- ClinicalTrials.gov ID
- NCT00363220
- Acronym / sponsor ID
- IRB# 0607059
- Keywords
- Infection, E coli, Klebsiella, ESBL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to review patients with E. coli infections at the University of Pittsburgh Medical Center (UPMC) from September 1, 2006 to August 31, 2007 to determine if these infections have arisen in the community rather than in hospitals or nursing homes. The occurrence of such resistant isolates could be devastating if they were associated with bloodstream infection, such as sometimes accompanies a urinary tract infection, since antibiotic resistant E. coli is not suspected in isolates coming from the community. Therefore, the aims of this study are to:
- Review whether extended-spectrum beta-lactamase (ESBL)-producing organisms (E. coli, Klebsiella species and Proteus species) are hospital-acquired, healthcare-associated, or community-associated.
- Investigate the prevalence of ESBL-positive E. coli in foodstuffs (beef, poultry, turkey, and pork), as a potential source for ESBL producers in the community.
- Compare the clonal relationship of the genome and resistance plasmids carried by the ESBL-producing isolates (healthcare-associated, community-associated, and of animal origin) and study the associations of ESBL-mediated resistance with resistance to other classes of antimicrobials.
Detailed description
The following variables will be followed: age, sex, occupation, hospital location at the time of positive culture (ER, medical ward, ICU, etc.), prior hospitalization or nursing home admission, receipt of outpatient dialysis, home care or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, and prior positive microbiologic cultures. All sites are collecting the following information that was collected as part of the patient's clinical treatment. The following variables will be collected at all sites: time and location of positive cultures, underlying diseases and severity of illness, presence of urinary or intravascular devices, recent immunomodulative therapies or radiation therapy, physical exam findings, laboratory and radiographical data, antimicrobial usage within 30 days of onset of the infection, microbiological data and resistance patterns, choice of antibiotics once the organism is identified, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome, gender, height, weight, ethnicity, and past medical history. We will collect information prospectively for one year. The bacteria in the patient's cultures will be subcultured (after the diagnosis has been obtained since the microbiology lab would otherwise destroy the culture) and provided to the honest broker who will de-identify the specimen and link it to the medical information collected (which will also be de-identified by the honest broker). The following evaluation will be performed on these samples. The minimal inhibitory concentration of the antibiotic used in treatment will be performed by the E-Test method (AB Biodisk, Solna, Sweden). Specific mechanisms of antimicrobial resistance will be studied with emphasis on the presence of beta-lactamases produced by the bacteria. This evaluation will be performed by analytical isoelectric focusing techniques as well as PCR and gene sequencing analysis to determine genes encoding beta-lactamases. Biologic samples will be under the control of the principal investigator of this research project. All samples provided to the investigators are de-identified by the honest broker and will be coded with numbers. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location that only the honest broker has access to. The investigators on this study will keep the samples indefinitely. Samples will be kept in the investigator's laboratory located in Scaife Hall, room 812, 3500 Terrace Street. At no time will the research investigators have access to any patient identifiers. Medical record information and bacteria samples from facilities outside of UPMC will be provided to the PI de-identified. At no time will anyone on the research team have access to patient identifiers. All information and bacteria are collected as part of the patient's clinical treatment.
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ESBL infections
Key inclusion criteria (5 listed)
- All patients with E. coli, Klebsiella species, and Proteus species infections during the time period of the study will be reviewed. A community-associated E. coli isolate will be defined as one which was recovered from a clinical culture from a patient at UPMC who had no established risk factors for infection with an antibiotic resistant organism. Established risk factors are defined as:
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yohei Doi, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection and E Coli Infections, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2015.